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Generics
The US Patent Trial and Appeal Board (PTAB) has denied the St Regis Mohawk Tribe's motion to terminate Mylan's patent challenge regarding six patents related to Allergan's dry-eye drug Restasis (cyclosporine). 26 February 2018
Pharmaceutical
In a dramatic reversal of fortunes, a US District court in Delaware has rescinded a prior decision compelling Gilead Sciences to pay $2.5 billion in damages to Merck & Co. 19 February 2018
Pharmaceutical
Privately-held US drugmaker Purdue Pharma is to cease its activities to push sales of its opioid drugs to doctors. 12 February 2018
Pharmaceutical
Within hours of gaining US approval for its new HIV treatment Biktarvy, which combines Descovy (emtricitabine/tenofovir alafenamide) with the integrase strand transfer inhibitor bictegravir, US biotech major Gilead Sciences has been slapped with a patent lawsuit. 8 February 2018
Pharmaceutical
Germany’s Bayer has started legal proceedings in Russia, filling a lawsuit against a local drugmaker Nativa, which registered a generic of Bayer’s anticancer drug prior to the expiration of the patent for the original drug, according to representatives of the German company. 7 February 2018
Pharmaceutical
The European Union’s General Court today delivered three landmark rulings for the European Medicines Agency, upholding the EMA’s decisions to release documents requested in accordance with Regulation (EC) No 1049/2001, the so-called “Transparency Regulation.” 6 February 2018
Pharmaceutical
Eli Lilly could face a bill in excess of $200 million if a French biotech’s charges against the US pharma company are upheld. 6 February 2018
Biotechnology
International aid group Médecins Sans Frontières (MSF) has launched legal action in South Korea to try to force a review of Pfizer’s pneumococcal conjugate vaccine (PCV) patent. 5 February 2018
Pharmaceutical
The US health insurance company Aetna has been handed a $1.15 million fine and a scolding from the New York State Attorney General for leaking patients’ HIV status. 25 January 2018
Pharmaceutical
The City of New York has initiated legal proceedings against eight opioid manufacturers and distributors, suing for half a billion dollars in damages to help fight the ongoing opioid addiction crisis. 24 January 2018
Pharmaceutical
A US appeals court has upheld a ruling invalidating a key Remicade patent, adding to Johnson & Johnson’s woes after declining sales of the therapy marred an otherwise positive results statement yesterday. 24 January 2018
Pharmaceutical
The Court of Justice of the European Union, the highest judicial body in the EU, has ruled that an agreement between Swiss firms Roche and Novartis may be in breach of European competition rules. 23 January 2018
Generics
The US Department of Justice announced on Friday that a federal court in New Jersey has imposed a $5 million civil penalty and entered a consent decree of permanent injunction against the US subsidiary of India’s Dr Reddy’s Laboratories. 22 January 2018
Pharmaceutical
A US administrative court has invalidated a US healthcare giant Johnson & Johnson’s patent on its blockbuster cancer drug Zytiga (abiraterone acetate), bringing rivals closer to selling generic versions. 19 January 2018
Biotechnology
The Broad Institute of MIT and Harvard University suffered a setback in its claim to intellectual property relating to the CRISPR gene editing technology yesterday, as the European Patent Office (EPO) revoked a patent granted to the institution. 18 January 2018
Generics
Drugmakers Ironwood Pharmaceutical and Allergan have reached an agreement with wholly-owned subsidiaries of India’s Sun Pharmaceutical Industries resolving patent litigation brought in response to Sun Pharma’s Abbreviated New Drug Application (ANDA) seeking approval to market a generic version of Linzess (linaclotide) prior to the expiration of the companies’ applicable patents. 17 January 2018
Generics
The UK BioIndustry Association (BIA) has been granted permission by the Supreme Court to intervene in its review of Warner-Lambert Company LLC v Generics (UK) Ltd and Actavis. 16 January 2018
Pharmaceutical
Israel's Justice Ministry said Monday it had fined the country’s largest drugmaker Teva Pharmaceutical Industries $22 million for bribing foreign officials in a settlement that spares the company a potential criminal trial, according to Israeli news service Abrutz Sheva. 16 January 2018
Biotechnology
Genentech has filed a lawsuit in the Tokyo District Court in a bit to prohibit sales of a biosimilar product of antiCD20 monoclonal antibody Rituxan (rituximab), marketed in Europe as MabThera. 11 January 2018
Pharmaceutical
Andrew Rut, chief executive of MyMeds&Me, a provider of adverse event and product quality capture software, considers in an Expert View piece how pharma’s ability to run efficient clinical trials is in danger of being compromised by GDPR and a hardening of attitudes on data privacy globally. 9 January 2018
Biotechnology
India’s Sun Pharma has been blocked in its efforts to launch its JAK inhibitor Leqselvi (deuruxolitinib) in the USA. 6 November 2024
article
The European Union's antitrust enforcer hit Israeli drugmaker Teva Pharmaceutical Industries (NYSE: TEVA) with a 463 million-euro ($502 million) fine Thursday for launching a smear campaign against a rival multiple sclerosis drug and misusing the patent system to thwart the competitor's attempt to entering the market. 31 October 2024
Biotechnology
UK pharma major GSK has sued USA-based Moderna this week, accusing the latter of violating patents protecting GSK’s COVID-19 vaccine. 16 October 2024
Generics
Two US units of Israel’s Teva Pharmaceutical Industries have agreed to pay $450 million to resolve two matters that allege Teva violated the Anti-Kickback Statute (AKS) and the False Claims Act (FCA), the US Department of Justice (DoJ) announced yesterday. 11 October 2024
Pharmaceutical
GSK has reached a settlement with 10 plaintiff firms, resolving 93% of the Zantac (ranitidine) product liability cases it faced in state courts across the USA. 10 October 2024
Pharmaceutical
Cardiopulmonary diseases specialist Liquidia Corporation closed Monday’s trading 11% higher following a favorable court ruling. 8 October 2024
Generics
Novo Nordisk has reached a settlement with Mylan Pharmaceuticals, now part of Viatris, putting an end to a US patent lawsuit over blockbuster diabetes treatment Ozempic (semaglutide). 8 October 2024
Pharmaceutical
Texas Attorney General Ken Paxton has filed a lawsuit against major pharmaceutical companies, including Eli Lilly (NYSE: LLY), alleging a conspiracy to artificially inflate the prices of insulin by up to 1,000%. 7 October 2024
Biotechnology
Bristol Myers Squibb has scored a major legal victory as a judge in New York dismissed a $6.4 billion lawsuit related to its acquisition of cancer company Celgene. 5 October 2024
Pharmaceutical
The US Department of Health and Human Services (HHS) has released final guidance for the second cycle of Medicare drug price negotiations. 3 October 2024
Pharmaceutical
Texas-based Cassava Sciences was trading 13% lower in Friday’s pre-market trading. 27 September 2024
Pharmaceutical
The Pharmaceutical Research and Manufacturers of America (PhRMA) is continuing its legal challenge against the US government’s drug pricing reforms. 24 September 2024
Pharmaceutical
On Friday, the USA’s Federal Trade Commission (FTC) brought action against the three largest prescription drug benefit managers (PBMs) - Caremark Rx, Express Scripts (ESI), and OptumRx 23 September 2024
Pharmaceutical
In a lawsuit filed in federal court in Missouri, USA, Health insurer Cigna (NYSE: CI) and its pharmacy benefit manager (PBM) Express Scripts demanded that the Federal Trade Commission (FTC) retract its July 2024 report. 18 September 2024
Generics
Several pharma companies that had moved the Delhi High Court against the government’s recent notification banning 156 fixed-dose combination (FDC) drugs have got a breather. 10 September 2024
Generics
Glenmark Pharmaceuticals has agreed to pay $25 million, based on its ability to pay, to resolve its alleged liability under the False Claims Act for conspiring to fix the price of a generic drug, the US Department of Justice announced. 5 September 2024
Generics
German pharma major Bayer has filed a lawsuit against the Russian drugmaker Promomed to protect the patent rights for Xarelto (rivaroxaban), its treatment for stroke prevention which is the best-selling drug in the Russian market at present, The Pharma Letter’s local correspondent reports. 2 September 2024
Biosimilars
Regeneron Pharmaceuticals has filed a lawsuit against Sandoz, alleging that its biosimilar to Eylea (aflibercept) infringes certain patents. 29 August 2024
Pharmaceutical
Ireland-headquartered Avadel Pharmaceuticals has updated on litigation with USA-based Jazz Pharmaceuticals. 29 August 2024
Pharmaceutical
Liquidia Corporation announced Thursday that it has filed litigation in the US District Court of the District of Columbia (Case No. 1:24-cv-02428) that challenges the recent decision by the US Food and Drug Administration (FDA) to grant three-year new clinical investigation (NCI) exclusivity to Tyvaso (treprostinil) DPI.9.6. 23 August 2024
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